10 Dec 00 - Medicine - Half million to be tested for UK gene map

Lois Rogers, Medical Correspondent

Sunday Times ... Sunday 10 December 2000

Scientists are to map the genes of Britain's population by taking DNA samples from 500,000 people.

Family doctors will be asked to write to all their adult patients aged 45 to 65 next year. The study could become a precursor of a national DNA database, eventually covering all National Health Service patients.

The first volunteers will answer background and lifestyle questions and give blood samples for a gene library. They will be monitored for serious illness over 10 years, while blood samples are analysed for links between genes and disease. The study, the first of its kind, is intended to explain the variation between rates of heart disease, cancer, stroke and diabetes in different regions and ethnic groups.

It will provide information about the protective effect of certain kinds of environment, diet or fitness levels on people with apparently high-risk genes. In addition, it will indicate the influence on the British gene pool of repeated invasions from Scandinavia and central Europe, as well as more recent waves of immigration.

Scottish and Northern Irish people have more heart attacks - and fewer teeth - than residents of other British regions. Celts have more spina bifida, and living in Britain vastly increases diabetes among Asians. At present, little is known about the effects of genes and lifestyle to explain the differences.

The study could help to trace how far height, strength and eye colour can be attributed to the different tribes, including Celts, Picts and Saxons, that have settled here.

Information about gene combinations that can increase susceptibility to disease is rapidly becoming available. The hope is that by studying people who have the gene combinations but do not become ill, doctors will learn how people can protect themselves from disease - by diet or environment changes, for example.

The project, run by the government's Medical Research Council (MRC) with support from the Wellcome Trust and the Department of Health, is the first large-scale genetic investigation into an ethnically mixed population. Similar projects have looked at Iceland and Estonia, both relatively isolated communities, which have remained genetically "pure".

Information from this kind of study is of huge value to drug researchers working on "magic bullet" therapies that target specific genes.

Part of the expected eventual cost of £40m will be offset by selling access to genetic data to pharmaceutical companies.

David Goldstein, Wolfson professor of genetics at University College London, is already involved in a study of Viking descendants. He believes there will be differences in genetic tendencies in different populations. "For example, genes affecting cholesterol levels could vary, and have a different impact on heart disease in different populations," he said.

Professor Steve Jones, a colleague at the university, said: "There has been a great deal of talk of using gene technology to create designer babies, but this project is much more likely to turn into something that will improve health."

10 Dec 00 - Medicine - Winston patents technique for 'designer sperm'

Lois Rogers, Medical Correspondent

Sunday Times ... Sunday 10 December 2000

A technique for genetically altering sperm to prevent children from inheriting unwanted characteristics from their fathers has been patented by Lord Winston, Britain's leading fertility expert.

The technique, developed by Winston in collaboration with researchers in California, involves modification of a man's germ line cells, which generate sperm, thus determining the traits passed to his offspring.

Although the intention is to use it to eliminate fatal diseases such as cystic fibrosis, critics fear it could be misappropriated to create designer babies.

Winston was not available for comment last week, but Phillip Koeffler, a co-worker at the Cedars-Sinai Medical Center in Los Angeles, admitted: "This does provide the capability of making designer babies, and it will be up to society to decide what to do with it."

Carol Readhead, a biologist at the California Institute of Technology in Pasadena, who has collaborated with Winston on research, pointed out that the sperm technology could also be used to create transgenic animals - those carrying human genes, which could become a source of human donor organs .

But she agreed the main use would be in man: "It is a difficult subject, a question which will come up again and again in the new century."

David King, a former geneticist who now leads the Campaign Against Human Genetic Engineering, condemned the technique, which he said would create a social gulf by conferring another advantage on the rich. "The commercial motive will mean ethical restraints are brushed aside," he said.

Although most of the research was done in America, Winston, a leading champion of the NHS, has obtained grant funding from the National Institutes of Health in Bethesda, Maryland, to carry out some of the work at the Hammersmith hospital, west London.

The controversial technique involves injecting genetic material directly into the testicle, using a virus to carry it directly into the developing germ cells.

The current method, banned in Britain, involves injecting DNA into embryos during test-tube procedures. A parliamentary debate next week is expected to lift that moratorium.

Winston's work does not contravene this law because it is using only sperm cells, which on their own do not have the capacity to become babies.

The Government's anti-flu campaign has been thrown into chaos by doctors who have pledged to disobey new official guidance on the only NHS drug to combat the illness.

The doctors have been warned that they could endanger lives by refusing to prescribe the drug Relenza this winter. However, doctors' groups have said that many other GPs are set to follow suit.

The Department of Health is hoping that Relenza will help keep elderly people with flu away from hospital, easing the expected NHS winter crisis. The anti-flu campaign had already been hampered by a shortage of vaccine.

The National Institute for Clinical Excellence (Nice) performed a U-turn last month and recommended that Relenza should be made available to certain high-risk patients during flu outbreaks, because it shortens the course of the disease by a day.

The decision has split the medical profession, with many doctors claiming that the drug is expensive and there is no evidence that it has an effect. The Medicines Control Agency, which licenses the drug, has said that it does not work, and the highly influential medical journal Therapeutics Bulletin also refused to back the drug. Professor Joe Collier, editor of the Bulletin, said: 'There's muddle and confusion. There's no reason to change our mind. We do not accept this recommendation.'

A group of mid-Devon doctors, representing more than 20 practices, voted not to prescribe the drug on cost grounds. Dr Charles Kent, their chairman, said: 'It's a drug we're not familiar with. I'm not prepared to prescribe a drug to my patients that I wouldn't take myself.'

The decision means that most patients in mid-Devon asking their doctors for Relenza will be turned away.

Nice has no powers to force doctors to prescribe the drugs it recommends, but the Department of Health is warning that those family doctors who do not toe the line could be in trouble. Nice's chairman, Professor Sir Michael Rawlins, said: 'I would like to remind them that a group of highly expert individuals have looked at this, which includes GPs. Just how will they feel when one or two patients in the primary care group dies of flu?'

GlaxoWellcome, which makes Relenza, had lobbied Nice hard to overturn its initial ruling that the drug was not worth prescribing. A GlaxoWellcome director sits on the Nice committee that assesses drugs; Nice insists he took no part in the decision to recommend Relenza.

The NHS Alliance, which represents GPs, said many more are likely to leave it to individual doctors to decide whether Relenza prescriptions can be justified. A spokesman said that, as extra money had not been made available to cover the £25-a-course cost of Relenza, many practices were reluctant to take money from other services to pay for the drug. 'If doctors are prescribing Relenza, they will have to make cuts elsewhere.'

Two bodies which provide legal assistance for doctors facing negligence claims, the Medical Defence Union and Medical Protection Society, have warned doctors they could face legal action if they disregard the advice of Nice.

A spokesman for the Department of Health said: 'The Department expects that Nice recommendations will be followed, although GPs obviously need to make their own clinical judgments. They are potentially letting themselves in for a bit of trouble if they don't follow them.'

09 Dec 00 - Medicine - Cannabis spray eases pain for MS patients

By David Sapsted

Telegraph ... Saturday 9 December 2000

Research into the medicinal benefits of marijuana is showing that three-quarters of a trial group of multiple sclerosis sufferers report significant benefits .

Interim findings from an experiment at an East Anglian hospital are regarded as an important step towards the legalisation of cannabis for medical use. In Government-backed tests at the James Paget Hospital, near Great Yarmouth, Norfolk, patients report remarkable benefits after using a cannabis spray.

Though the trials are small in scale, 10 of the 13 guinea pigs, multiple sclerosis sufferers or people experiencing severe pain after surgery, have reported finding relief. Benefits include relief from pain, enabling sufferers to sleep better and allowing a return to more active lives.

Dr Willy Notcutt, leading the trial, said: "The results so far are very acceptable." Alan Milburn, the Health Secretary, has stated the Government's willingness to legalise the medical use of cannabis if trials show it can be of "a clear benefit".

09 Dec 00 - Medicine - Cannabis tests show relief of long-term pain

By Nigel Hawkes, Health Editor

Times ... Saturday 9 December 2000

The doctor leading a trial into the medical benefits of cannabis has said that more than three quarters of those with chronic pain have been shown to benefit from using it.

Willy Notcutt, of the Pain Relief Clinic at the James Paget Hospital in Great Yarmouth, said: "There's no doubt in our minds that a large number of patients have gained benefit - between 70 and 80 per cent.

"That's actually very good results for people with long-standing pain, although not all the benefits are in the relief of pain, but in the quality of life.

"We have one patient who has actually gone back to work, albeit in a part-time capacity, doing manual stuff. That's a very important bonus, that patients can actually find that they can do a lot more even with the same amount of pain."

The trials have been financed by G.W. Pharmaceuticals, which developed a way of admistering the drug as a spray under the tongue.

"A joint is a very good system for delivering cannabis but it's impossible to do any research into it because you don't know what you are getting," Dr Notcutt said.

"From a medical point of view we do not give any drugs to patients by telling them to burn it themselves and inhale toxic smoke."

The Royal Pharmaceutical Society is currently monitoring two larger trials of the use of the drug: a £400,000 study involving 300 patients to see if cannabis tablets can replace morphine as a painkiller after surgery and a £900,000 study of 660 patients with multiple sclerosis. Both trials are funded by the Medical Research Council.

"We have had to do this research very much on a shoe-string," Dr Notcutt said. "It's not easy to get money for research and added to that we have had disparaging remarks because we are a district hospital."

A drug has been shown to slow deterioration in the way patients with Alzheimer's disease function in their daily lives, according to research published today which will strengthen the case for such drugs to be prescribed on the NHS.

There has been much controversy about the three drugs now in use for Alzheimer's, of which galantamine (Reminyl ), the subject of the latest research, is one. All three - the others are donepezil (Aricept ) and rivastigmine (Exelon ) - are cholinesterase inhibitors and work in the same way.

While the families of Alzheimer's sufferers want the drugs to be prescribed on the NHS and claim they improve their relatives' quality of life, some specialists have argued that the studies so far only show benefits that are measurable in terms of scores on tests.

But the latest study, according to the Alzheimer's Disease Society, has a different design. It was funded by the manufacturers and published in this week's British Medical Journal.

It claims to find "significant benefits" for patients' daily living. There was an improvement in a small number of cases, but in a large number the deterioration usually seen with Alzheimer's was slowed.

Gordon Wilcock, professor of care of the elderly at Frenchay hospital, University of Bristol, and colleagues, investigated 653 patients with mild to moderate Alzheimer's disease attending 86 outpatient clinics in Europe and Canada.

The results showed that the condition of 50% of patients who received a placebo declined. This compared with 38% of those on a lower dose of galantamine and 35% of those on a higher dose.

In 33% of those on a placebo there was no change, compared with 44% and 41% of those on low and high dose galantamine respectively.

The research has gone to the national institute for clinical excellence, which is considering whether to recommend that this class of drugs be made available on the NHS.

08 Dec 00 - Medicine - We haven't got time for the pain

By Marina Cantacuzino

Independent ... Friday 8 December 2000

"Just knock me out at the first twinge, then wake me up in the hairdressers," was the comedian Joan Rivers' idea of the ultimate pain-free labour. It was, of course, a witty one-liner, but also a pertinent statement about women's increasing demand for intervention. Natural birth remains the choice of a small minority of women, who take on non-medicalised childbirth often as a crusade and are therefore viewed suspiciously by many midwives and obstetricians.

There has been a marked rise in Caesarean sections in the UK in recent years. In 1970 Caesarean sections in England and Wales accounted for less than 3 per cent of births. Just three years ago, an Audit Commission report stated that 11-18 per cent of babies were delivered by that method. Now, that number has risen to 30 per cent in certain hospitals, even though the World Health Organisation says that there is no justification for a Caesarean rate of over 10-15 per cent.

The seemingly unstoppable rise in the UK section rate is part of a growing movement created by doctors and patients in pursuit of the easy birth. Reports out this week of a new drug currently being developed by the company Ardana Bioscience are all part of this trend. The drug works by "ripening" the cervix and making it more elastic, so that a baby is born more easily. It is meant to make labour quicker, safer and less painful by reducing the length of first-time labours, which can be as long as 18 hours.

Beverley Beech, honorary chairman of the Association of Improvements in Maternity Services, is not impressed. "I felt a cold shudder when I read about the drug," she says. "Why do women want labour sped up? It's obstetricians who want it and kid women that it's a good thing. To talk of an 18-hour labour is misleading; women think it means 18 hours of pain, when in fact they're slowly working up to a crescendo. How many shocked, distressed babies are we going to get out of this?"

In Beech's view, the increasing medicalisation of labour is a cost-cutting exercise in the NHS. The intention, she believes, is to use fewer staff, free up hospital beds and get women out of hospital sooner.

"The risks of a section are horrendous," Beech says. "It lowers fertility and creates post-op complications, as well as increasing the risk of problems in the next birth. Also, studies have shown that women are less satisfied with the birth and less likely to breast-feed as a result. You are also five times more likely to die from a Caesarean section than from a normal vaginal birth."

Julia Cooper, 28, gave birth to her first child this year. She had planned a home birth until, at 36 weeks, she was told the baby was too big and there was a chance of shoulder dystocia. When she asked her obstetrician for more information so as to be able to make an informed decision, a midwife was summoned, who told her that she'd been present at two shoulder dystocia births, one of which had been fatal.

Unconvinced by that anecdotal evidence, Julia asked to continue with her home-birth plan, but the midwives refused to support it. "I was told I had to have a Caesarean, that Caesareans were safe and getting safer all the time. They said in a few years' time everyone would be having them. What could I do but consent? But, unfortunately, there were complications, and they illegally hysterectomised me. I had told them not to, but they did without my consent."

Julia is suing the hospital. Worst of all, she has been told by five separate experts that on medical grounds the operation was unnecessary. The experience has shattered not only her faith in the medical profession but also her dream of having a big family. She is now exploring the option of surrogacy but feels extremely bitter at having to resort to such expensive and distressing methods. "It's been a horrendous year," she says, "and I'm now convinced that obstetricians are just scalpel-happy."

With obstetricians taking a lot of flak for the rising Caesarean rate, one excuse they often give is that women are demanding it. According to Professor Edith Hillan, from the department of nursing and midwifery at Glasgow University, women such as Victoria Beckham, Patsy Kensit and Madonna have set the trend by having elective Caesareans. "Women are increasingly reluctant to have a great long labour," she says. "Of course, a section isn't always for the wrong reason and is often life-saving, but we need to be asking why a quarter of women suddenly want them when the procedure comes with a risk that wouldn't be associated with vaginal delivery."

Yvonne Williams of the Caesarean Support Network puts it down to ignorance. "The vast majority of women are not educated about childbirth. A hundred years ago, it was different, when women were delivering one another's babies at home. Now, they think they can jump off the operating table and walk. Some women who ring me think that by having a section they're doing away with pain and risk, but I have to point out that it's major surgery they're having."

Williams has only praise for Cherie Blair. "A lot of us were expecting her to have a Caesarean, but instead she went the natural way and did a lot of good by showing women that they shouldn't be frightened of labour."

Belinda Allen decided to go the natural way when she had her first child. "I went to antenatal yoga classes in Notting Hill, run by a woman whom everyone considered the guru of natural birth. She told me birth would be a deep and enriching experience, advising us to 'moan like a cow'. Later, I also went to see Christine Hill, who was much more down-to-earth and talked about your vagina being the size of the Grand Canyon. She told it like it was. I actually think making you feel guilty for not having a natural birth does a hell of a lot of harm, because it plays on women's terror."

Belinda's planned natural birth came to nothing because the baby was two weeks overdue and finally had to be induced. A long, painful labour followed, resulting in an emergency Caesarean after 24 hours. "You couldn't get a more sterile, sanitised birth than mine, nor a more painful one. I had every single kind of pain relief and medical intervention you can imagine."

Even so, despite the relief of having the doctors intervene, she wishes they had either opted for a Caesarean (instead of going through hours of failed attempts to get the baby out with forceps and Ventouse) or simply waited to let nature take its course. "I can't help wondering, if they hadn't induced me with Syntocinon, which speeds up contractions, and if they hadn't given me an epidural, which slows down labour, then perhaps the whole thing would have been far less traumatic. After all, on the day of being induced, my waters broke naturally, so perhaps the baby would have come out on its own if they hadn't started sticking tubes in me."

Beverley Beech points to Belinda as one of a growing number of women who are told there's no point going into labour, because they're likely to have a Caesarean anyway. Having had one section, Belinda went on to have two more because, as she says: "They told me I had a 25 per cent chance of getting out the babies naturally, because of the shape of my pelvis, and I couldn't face the thought of trying and failing."

Some time ago, a woman I know sent me the following account: "On the day of the birth, my lover filled the room with pink and red roses and church candles. I received two messages from friends, with oils of jasmine and rose, recommended to prepare women for labour. I also had acupuncture to tune my body to its maximum birthing capacity. As the midwife massaged me, the labour began, and we filled the birthing pool with water. When the pain became more intense, I slipped into the water and allowed it to support and soothe my body. Four hours later a beautiful little girl was born. The energy in the room was wild."

Such scenes do not occur in labour wards or hospital operating theatres, and although many strive for that kind of experience, many more share Joan Rivers' desire to be as comatose and removed from the barbaric act as humanly possible.

08 Dec 00 - Medicine - Protein targeted in breast treatment

By Mark Henderson, Science Correspondent

Times ... Friday 8 December 2000

Women with breast cancer who have high levels of a sugar-protein molecule in their bodies are less likely to survive the disease, according to a new study.

Researchers found that over an average time of 10.8 years, the likelihood of dying was about double for women with high levels of the protein Ep-CAM . The molecule is known to be overproduced in tumours associated with bowel and breast cancer. It acts as a cell adhesive and could have a role in causing cancers to spread around the body.

As a result, it offers a good target for new treatments to prevent secondary cancers, the researchers from Innsbruck University Hospital, Austria, said in The Lancet.

08 Dec 00 - Medicine - Venereal disease resistant to drugs

By Nigel Hawkes

Times ... Friday 8 December 2000

The treatment of gonorrhea in Scotland is being threatened by the emergence of a drug-resistant form.

One case in 20 investigated by a team from Edinburgh University Medical School turned out to be less easily treated than before using the antibiotic ciprofloxacin , and 2.2 per cent of cases were completely resistant.

Resistance to the antibiotic has been growing in the Far East and the evidence is that the resistant strains are being introduced into Scotland by "sexual tourists". Thailand was the largest single source.

The danger is that the imported version will spread within Scotland, as is already happening. The team responsible for the report suggest in The Lancet that gonorrhea caught abroad ought not to be treated by ciprofloxacin .

Dr Hugh Young and colleagues reviewed the degree of gonorrhoea resistance to ciprofloxacin - marketed as Ciproxin by Bayer - over an eight-year period. Samples were taken from 4,415 infections.

The researchers found that the proportion of cultures with lowered susceptibility increased from 0.5 per cent in 1991 to 5 per cent in 1999. The proportion of cultures with clinical resistance was significantly higher in 1999, at 2.2 per cent, than the average for the preceding four years (0.9 per cent).

LONDON (Reuters) - The Scottish scientists who created Dolly, the world's first cloned mammal, announced a deal with U.S. biotech company Viragen Inc to breed chicken that produce life-saving drugs in their eggs.

Dr. Helen Sang, of Edinburgh's Roslin Institute said the deal will combine the nuclear transfer technology used to make Dolly with Viragen's expertise in developing anti-cancer proteins.

"The essence of this project is to create chickens which produce eggs containing new drugs to treat many serious diseases, including cancer," Sang said Wednesday in a statement.

Roslin scientists are already developing cows, sheep, goats and rabbits to provide proteins for drugs in their milk but birds provide a cheaper, faster and virtually unlimited production process through laying eggs.

"This collaborative effort is being undertaken to enable the production of a wide variety of drugs in greater volume and at a fraction of the cost when compared to conventional manufacturing methods," explained Gerald Smith of Florida-based Viragen.

NO SIGN OF BRITNEY THE CHICKEN

News of the deal that was announced at Edinburgh Castle was leaked in British newspapers during the weekend, along with news that Britney, reportedly one of a flock of genetically modified birds, would make an appearance.

But it seems to have been a case of counting eggs before they are hatched.

"There is no Britney," a Roslin spokeswoman told Reuters.

"The announcement is about work to be done in the future. It is not done yet," she added.

Dolly the sheep was produced by taking the nucleus out of a cell from the mammary gland of an adult animal and fusing it, using an electrical current, into another sheep egg cell from which the nucleus had been removed.

The same technology will allow scientists, for the first time, to precisely control where and how genes are inserted into hens.

"The collaboration with Viragen is a key part of our strategy to expand the institute's development of medical applications of Dolly technology," said Professor Grahame Bulfield, the director of the Roslin Institute.

TranXenoGen Inc (TXN.L>, a British company that specializes in the production of human therapeutic proteins in chicken eggs is working on a similar project.

It is estimated that the genetically modified chickens will lay about 250 eggs, containing proteins for drugs, a year.

Viragen is collaborating with Britain's Cancer Research Campaign to develop a vaccine for the treatment of breast, ovarian and colorectal cancer.

It is also working with the Memorial Sloan Kettering Cancer Center in New York on a treatment for skin cancer.

Viragen's lead product, a treatment for hepatitis C called Omniferon, is being tested in clinical trials in Europe.

A pint a day is good for the brain cells , according to a Japanese study that found moderate drinking can improve intelligence.

A team from the National Institute for Longevity Sciences tested the IQs of 2,000 people aged from 40 to 79. They found that on average men who drank moderately had an IQ 3.3 points higher than those who were teetotal. Women drinkers scored 2.5 points higher than females who did not drink.

The Japanese scientists defined moderate drinking as fewer than 540ml - almost a pint - of sake or wine a day. They said the type of alcohol did not influence the results. Volunteers drank beer, whisky, wine and sake.

Not surprisingly, the scientists concluded that drinking alcohol excessively impaired intellectual ability. But the team said the findings had to be treated with caution. It might be that people who drank were brighter in the first place and the alcohol still impaired their intelligence, but not to the level of the teetotallers.

Hiroshi Shimokata, the chief researcher, said: "It's very difficult to show a cause-effect relationship. We screened subjects for factors such as income and education but there may be other factors such as lifestyle and nutritional intake."

Dr Shimokata said people who drank sake, or Japanese rice wine, tended to eat more raw fish. This might have affected the results as fish contained essential fatty acids that had been linked to brain development.

Similarly, wine drinkers ate a lot of cheese, something that the Japanese did not usually consume. Dr Shimokata said the high fat content of cheese was thought to be good for the brain.

The scientists who created Dolly the sheep yesterday announced plans to clone chickens to become living factories producing human cancer drugs .

Work is under way at the Roslin Institute, near Edinburgh, to alter hens genetically to make them lay eggs with designer anti-cancer proteins contained in the egg whites.

These proteins can then be extracted easily and used to create drugs to treat patients.

If successful the Avian Project will result in a new generation of cancer treatments which can be produced in large quantities much more cheaply than at present, making them accessible to many more cancer patients. At the moment cancer-fighting proteins are manufactured in a laboratory which is an expensive and slow process.

The project still has a number of technical difficulties to overcome, but scientists at Roslin are confident that they will have cloned the first cancer chicken within a year.

Viragen, an American drug company, is funding the project and the first protein produced in a chicken is expected to be based on one of its treatments for skin cancer.

It is thought that the technology will be adaptable and Viragen plans to make it available to other companies producing treatments for other diseases.

Helen Sang, head of the Avian Project at Roslin, said the creation of Dolly had shown the future potential of the technology.

"The next stage is to deliver the benefits of the Dolly technology to an expectant world. Avian technology promises a much faster, cheaper and virtually unlimited production process marked by the chicken's prolific egg laying capacity."

Dr Sang has already successfully bred transgenic chickens which can produce human proteins in their eggs. However only a small number of their offspring carry the protein, making the process inefficient.

By cloning identical chickens, each genetically adapted to produce proteins, that problem will be overcome. Flocks of chickens can then be bred easily to become natural pharmaceutical factories.

Ian Wilmut, the man behind the creation of Dolly, the first animal to be cloned from an adult cell, said that Roslin was unique in having both the cloning and the transgenic chicken technology to make this leap.

Many new anti-cancer treatments are protein-based but are complex and difficult to produce in quantity with traditional methods.

"The existing technology is expensive and there is a growing and urgent need to produce these new drugs in quantity. I am very confident that we will achieve our goal," said Dr Sang.

06 Dec 00 - Medicine - Scientists crack designer eggs

By BBC science correspondent David Concar

BBC ... Wednesday 6 December 2000

The scientists who made history by producing Dolly the Sheep clone say they are now attempting to create designer chickens whose eggs may help to produce drugs to fight cancer.

By altering the hens' genetic make-up, they want to transform the birds into living pharmaceutical factories.

The drugs in question are complex proteins that may prove effective in treating lung and skin cancer. They have been identified as potential cancer therapies by an American drugs company called Viragen.

At present, though, the company's research is stymied by the fact that it can only make the proteins in tiny quantities and at huge expense. So it has struck a deal with the Roslin Institute in Edinburgh, UK, to develop genetically modified chickens capable of mass-producing the substances in the whites of their eggs.

"This collaborative effort is being undertaken to enable the production of a wide variety of drugs in greater volume and at a fraction of the cost when compared to conventional manufacturing methods," said Viragen's chairman Gerald Smith.

'Valuable proteins'

Modifying the genes of birds is technically challenging. But two years ago, the Edinburgh team discovered how to insert new genes into the embryos of chickens to create GM hens.

The birds they have created so far do not produce anything useful. But the next generation will carry the genes needed to make the anti-cancer proteins, insists Dr Helen Sang of the Roslin Institute. And the ultimate aim, she says, is to create designer birds using the cloning technique used to make Dolly the sheep.

"Technology used to create Dolly has allowed the production of valuable proteins needed for drug development in the milk of mammals," said Dr Sang.

"We now intend to take this technology a step further and develop transgenic chickens to produce eggs rich in protein-based drugs to treat cancer and other serious diseases."

The Roslin team faces stiff commercial competition from rivals in the US. AviGenics of Athens, Georgia, says it already has chickens capable of manufacturing an anti-cancer protein called interferon, while GeneWorks of Ann Arbor, Michigan, claims it has a flock of between 50 and 60 genetically engineered hens. Some carry a gene that enables them to make a human growth factor in their eggs.

Pharmaceutical powerhouse

If things go well for the rival teams, the humble hen's egg will be transformed into a pharmaceutical powerhouse manufacturing life-saving drugs to order.

But already there are concerns about the same technology being used to create GM chickens for the dinner table.

The announcement was given a cautious welcome by the Church of Scotland. Dr Donald Bruce, director of its Society, Religion and Technology Project, warned animals should not be mistreated.

"We support the general aim of Roslin's research into antibody production using chicken eggs," said Dr Bruce.

"Care must be taken, however, that it does not pose undue animal welfare problems and that human safety implications are fully addressed."

05 Dec 00 - Medicine - Catholics try to halt tests on cloning

Staff Reporter

Guardian ... Tuesday 5 December 2000

The Catholic University in Rome is to set up a research centre in an attempt to provide an alternative to the cloning of human embryos for medical research, it has emerged.

The university plans to create a "placenta bank" to store stem cells which they hope will allow them to regenerate human organs and tissue without the need for cloning.

The development comes as MPs in the UK prepare to debate a proposed extension to the 1990 Human Fertilisation and Embryology Act which would allow therapeutic cloning, the creation of embryos with a genetic make-up identical to a living adult for medical research. The law in Britain already allows research on human embryos up to 14 days old for fertility treatments.

Scientists believe research into stem cells harvested from embryos could lead to treatments for illness including Parkinson's disease and Alzheimer's.

But the Catholic church has protested that therapeutic cloning will lead to cloned human beings because the basic scientific method is the same.

The alternative research facility was revealed yesterday by Cardinal Thomas Winning, the leader of Scotland's Roman Catholics and chairman of the bioethics committee of the Bishops' Conferences of the UK and Ireland. He said the placenta bank offered possibilities which could prove greater than those in therapeutic cloning.

Writing in The Herald, Cardinal Winning said: "In recent months, it has become increasingly clear that there is an ethical alternative to cloning embryos. This involves the harvesting of cells either from an adult or from a newborn baby's umbilical cord. Such cells can then be "trained" to grow in the same way as embryo-clone cells and may offer the same hope of treatment without any of the ethical problems associated with cloning."

A spokesman for the Catholic church in Scotland, Father Paul Murray, said they were aware that the science was not yet there to use placental or adult stem cells for therapeutic purposes, but argued that the same could be said for embryo research.

"Most of the science is still relatively far off," he said. "That is why it is a significant time in terms of choosing a particular road to go down. Our fear is that the British government has decided almost exclusively to go down the road of therapeutic cloning research on embryos."

Experts said that more work would need to be done on adult or umbilical blood stem cells before they could be said to hold the key to fighting disease.

James Lovell-Badge of the Institute of Medical Research said that, in theory, stem cells from the blood of an umbilical cord could treat diseases of the blood, but there was no evidence they could be used for anything else. It had not been shown that cells from the placenta can give rise to any other tissue type.

However there was no harm in further research in this area. "It is just a long way off in terms of any potential therapy.

"Our view generally is that we would love to do research on embryonic stem cells because we know their potential to give rise to any cell in the body. However, we would also support research on other sources of stem cells whether from an adult or foetal cord blood."

05 Dec 00 - Medicine - Call for cancer drug licence

By Nigel Hawkes, Health Editor

Times ... Tuesday 5 December 2000

An aggressive form of lymphoma can be treated more successfully with a new drug, it was claimed yesterday.

Mabthera, made by Roche, produced improved rates of survival after a year when combined with conventional cancer drugs, a conference in San Francisco organised by the American Society of Haematology was told.

Of 328 patients with aggressive non-Hodgkin's lymphoma, 83 per cent treated with the combination were alive a year later, compared with 68 per cent of those given conventional drugs alone.

More than three quarters showed complete remission, compared with 60 per cent of those on conventional drugs. The trial was carried out by the Group for the Study of Adult Lymphomas, a cancer co-operative which covers 130 institutions in France, Belgium and Switzerland.

The drug is licensed in Britain for the treatment of low-grade lymphomas, but not for the fast-growing version addressed in these trials. Roche is expected to apply for a wider licence.

It could take some time before it is able to win a licence, however, and the drug will also have to be approved by the National Institute for Clinical Excellence.

Alan Bartle, of the Lymphoma Association, said: "Thousands of British patients could benefit from Mabthera, but for some the long wait could be too late."

04 Dec 00 - Medicine - GM hen's eggs put on cancer cure trail

Tim Radford, science editor

Guardian ... Monday 4 December 2000

A hen genetically modified to produce anti-cancer proteins in her egg whites could be about to cause a stir in the pharmaceutical industry .

The chicken, dubbed Britney, is expected to be formally introduced to the world in Edinburgh on Wednesday by her makers at the Roslin Institute, in Scotland. Scientists at Roslin cloned Dolly the Sheep in 1997, but they are also among the world leaders in the "pharming" of animals.

Until now Britney - revealed in the Mail on Sunday - has been kept in the dark of the henhouse, and yesterday there was no information either from Roslin nor the institute's commercial partner in the project, a US firm called Viragen, about the proteins such hens could provide.

Viragen is working with the UK Cancer Research Campaign on a treatment based on the human immune system.

The use of genetically engineered farm animals to make such proteins is becoming commonplace: goats and sheep in Europe and the US are under trial for various milk-based products.

Until now hens have not laid any golden eggs for the pharmaceutical companies. Britney's 250 eggs a year could provide the building blocks for drugs to treat melanoma and ovarian and breast cancer.

However, Viragen and the Roslin researchers have yet to reveal how. And any useful product could be years away from the pharmacy.

"There's no evidence they have done anything yet. There is no peer reviewed paper that I am aware of. Presumably on Wednesday everything is going to be revealed," said Gordon McVie, director of the Cancer Research Campaign. "All they need to do is show they've done it with one protein. Then the technology is there to be used. Well, name your favourite protein."

04 Dec 00 - Medicine - 'Unacceptable delays' in cancer testing

James Meikle, health correspondent

Guardian ... Monday 4 December 2000

The NHS's care of cancer patients may have been compromised by "unacceptable delays " at a leading bone cancer unit in reporting the results of post-operation tests, a report reveals today.

A combination of failures at the Royal National Orthopaedic hospital in Stanmore, north-west London, over at least five years contributed to such a backlog on samples from around the country that its testing service was considered "potentially unsafe" even by its management.

Consultants had to wait up to year to get results, the report found. One patient committed suicide after waiting five months for a test that showed his operation had been unsuccessful. The hospital says tests are now reported within three months, with the aim of making this two months, and it has also set up a results hotline for anxious patients.

Today's report concludes that between 1991 and 2000, 15% of tests on tumours or tissue removed in bone cancer operations were either not reported or suffered unacceptable delays. Attempts to remedy this began in 1995 following concerns raised by a cancer specialist, but by September 1999, with delays up to nine months, managers conceded an investigation was needed. Investigators from outside concluded that the care of only three patients had been demonstrably affected, but one senior surgeon told them he believed his service to patients had been compromised because he was having to make decisions when "[an] important part of the jigsaw was missing".

Jacky Sherman, chief executive of the hospital trust, will today apologise to the three patients and their families, to whom it has offered counselling, and promise the highest standards in future; it has already acted on some of the report's recommendations.

A coroner linked the suicide of one man to a five-month gap between his operation and being told there was still evidence of cancer; test results were ready in three months, but it was a further two months before he was told.

Another man ended chemo-therapy four months after a tumour was removed from his leg and three months before a lab report on the tissue removed indicated that complete removal of the cancer was "at best dubious"; after further surgery and radiotherapy his leg was amputated above the knee. A woman finished chemotherapy after the removal of a leg tumour, but six months after the operation she was told she might need radiotherapy. Neither of these two has yet displayed signs of secondaries.

Overall, investigators from the local Brent and Harrow health authority said that psychological effects on patients and their families "were almost inevitable", although the extent could not be quantified.

The investigation revealed personality clashes and lack of leadership by top managers. Jean Pringle has been removed as head of the histo-pathology department, which provides the "essential and irreplaceable" testing service. Investigators formed the opinion Dr Pringle was highly regarded as a diagnostician and her medical skills were valued by colleagues, but they criticised blurred responsibility between hospital management and that of the Institute of Orthopaedics at University College, London, which employed Dr Pringle, and where she had academic responsibilities. The two had "conflicting agendas and priorities".

The report has ordered a full review by the hospital of its management, while the new NHS watchdog, the commission for health improvement, will make sure improvements have been carried out next year.

Today's verdict, coinciding with an attempt by Tony Blair to reassure the public the NHS can cope with a winter crisis, follows last month's revelations of failure at another supposed beacon of excellence, the Oxford heart centre. The Guardian also reports today on feuding and lapses at a hospital in Plymouth.

04 Dec 00 - Medicine - Sales of anti-depressant soar as we become nation of pill-poppers

By Jeremy Laurance, Health Editor

Independent ... Monday 4 December 2000

Prozac has been one of the great marketing success stories of the last decade. Since its launch in 1989, sales of the anti-depressant have soared to more than three million prescriptions a year in the UK, and in 1999 its worldwide earnings were $2.6bn (£1.8bn)

Some people have seen this as a worrying trend, a sign of the excessive demands being made on people by modern life and evidence that Britain is becoming a pill-popping nation. But the development should be seen as a cause for celebration, not consternation. It is a sign that misery is at last being treated seriously.

One of the most serious of our social ills is the unreasonable fear of psychoactive drugs, a fear that will be fuelled by the coming court case.

Depression exacts a huge toll of human suffering, much of it unnecessary because effective treatment is easily available. It takes the lives of more than 4,000 people a year, many of them young, by suicide. Resistance to drugs, fear of the stigma of mental illness and professional reluctance to investigate emotional problems conspire to keep the suffering hidden.

Most people have no difficulty with the beta blockers prescribed to millions to control their blood pressure, or the insulin given to diabetics to control their glucose level, but suggest a pill to boost serotonin levels (the brain chemical linked with depression) and they react as if confronted by a drug pusher.

There are self-help techniques for dealing with depression - cognitive behaviour therapy, a strategy based on positive thinking, for example - as there are for holding blood pressure down - such as exercise. But many people find them impossible to apply or that they do not work. Then drugs should be an option.

Many reject drugs because they fear they will become dependent but this is based on a misapprehension.

Anti-depressants such as Prozac are not addictive, even after many years of use. They are chemically different from the benzodiazepine tranquillisers such as Valium, which are addictive, and which are now only used for short-term treatment of a few weeks.

There is also a deeper, moral, fear typified by the "pill-popping" headlines. This is the view that doctors who hand out Prozac are dispensing happiness in a pill and should be classed with barmen pouring whiskies or dealers selling cocaine.

It, too, is based on a misapprehension. Anti-depressants do not provide pleasure, they restore the capacity for pleasure.

There are some concerns about the side effects of Prozac and its cousins that deserve investigation and will be highlighted in the court case.

Allegations that the drugs have in rare cases provoked people to acts of violence, against themselves or others, have rumbled on for years. Against this, however, has to be set the fact that anti-depressant drugs also save the lives of countless people whose despair has driven them to the edge of suicide.

For almost a decade the Royal College of Psychiatrists has run a campaign to counter the stigma of depression and encourage more people to seek treatment. The rise in prescribing is testimony to its success. But there is still a lot of untreated misery out there. It would be tragic if this case reversed the rising trend.

A Drug has been developed that could make childbirth quicker , safer and less painful by reducing labour to two or three hours, even for first-time mothers.

It works by mimicking the natural chemistry in the body that dilates or "ripens" the cervix and it could increase the percentage of natural births and cut the number of caesarean sections.

Nikki Brimicombe, of Ardana Bioscience, the company behind the development, said it would allow babies to be born with greater ease and would save mothers experiencing labour that lasted more than 12 hours.

She said: "For many mothers, childbirth can be a very lengthy and painful process, particularly if it is their first child. The ripening agent works by targeting collagen in the cervix and breaking it down. This allows the cervix to relax and become more elastic, which means it can widen more easily to allow the baby to be born."

Collagen, a fibrous protein, makes the cervix stiff and inelastic. Compounds produced during the last few weeks of pregnancy cause a gradual breakdown of the collagen, allowing the cervix to relax. But in women giving birth for the first time, or who are induced by doctors, the process is often incomplete at birth. That can cause painful stretching of the cervix and prolong childbirth for hours.

The drug, which has not been given a name, has been successfully tested on animals and clinical trials will be carried out in Scotland next year. It could be on the market within five years.

Professor Edith Hillan, from the department of nursing and midwifery at Glasgow University, said: "Women can tolerate pain in childbirth for a limited amount of time and, in prolonged births, it can often be too much. When this happens, epidurals are administered but there is concern about the impact they have on the baby and the mother.

"On average for a woman having her first child, the birth can last for 18 hours, while those having a second child will be in labour for eight. Whether mothers will use this drug depends on the individual and many, given the choice, will be very grateful."

The drug company, an Edinburgh-based offshoot of the Medical Research Council, was set up to develop drugs for women's health and is working on a birth control pill taken once a month.

04 Dec 00 - Medicine - GM chicken eggs will help cancer battle

By Auslan Cramb

Telegraph ... Monday 4 December 2000

The scientists who created Dolly the sheep, the world's first cloned animal, are about to reveal a genetically modified chicken that lays eggs containing cancer-fighting protein .

Britney has had its DNA altered to produce eggs with whites that are especially rich in such protein. The protein will be used by Viragen, an American biotechnology company, to develop a cancer vaccine, an antibody and a "magic bullet" designed to destroy individual cancer cells.

Viragen sponsored the research in a joint venture with PPL Therapeutics, the commercial arm of the Roslin Institute in Edinburgh. Researchers are expected to announce on Wednesday that they succeeded in altering the hen's genetic material to produce up to 250 GM eggs a year.

Dolly the sheep, cloned from mammary cells, was named after Dolly Parton, the singer. It is not yet known why the hen was called Britney, presumably after the American pop singer.

04 Dec 00 - Medicine - Blood cancer drug opens new horizons

By Dr Thomas Stuttaford

Times ... Monday 4 December 2000

A dramatic advance has been made in the fight against cancer after a new drug, which has already proved its worth against one form of leukaemia, saved a woman with a rare tumour and destroyed the malignant disease that was killing her.

Experts believe that the revolutionary advance in the treatment of the leukaemia can now be applied to other forms of similar cancer.

The new drug, known as Glivec (formerly called STI571), from the pharmaceutical company Novartis, has been shown to react well during clinical trials against Chronic Myelogenous Leukaemia (CML). This is a comparatively slow developing leukaemia known to account for about 12,000 deaths annually.

Novartis scientists targeted CML because it is an unusual malignancy in that the chromosomal abnormality which is the root cause of the cancer is well understood. A total of 95 per cent of patients who develop CML have an abnormal chromosome, named the Philadelphia chromosome, found in one type of their white blood cells.

Other cancers are not so well understood as CML, but now that it is possible to use a form of chemotherapy which is relatively free of side affects, to tinker with the chromosomal make-up of the patients' white blood cells, and thereby achieve a remission of symptoms, the hunt is on to see which other cancers might respond in a similar way.

It is reported that 90 per cent of the 3,000 patients involved in the clinical trials of Glivec, all of whom had failed to respond to standard existing treatment, went into remission after treatments and have continued to do well.

The haematologists were particularly pleased by the response because tests have shown that in 50 per cent of the patients who went into clinical remission, the number of rogue Philadelphia chromosomes detectable in white cells had been remarkably reduced.

CML, also known as Chronic Myeloscytic Leukaemia and, to an older generation of doctors, as Chronic Myeloid Leukaemia, occurs in any age group but is rare in very young children.

The median age of the onset of CML is between 40 and 50. It affects men and women equally.

Leukaemias generally described by the public as cancers of the blood are classified according to the type of blood cell which is involved in the malignant process and the maturity of the affected cell. In acute leukaemias the affected blood cells are immature and the disease, without treatment, usually runs a rapid downhill course. In the chronic leukaemias, the cells are more mature and the progress of disease is usually more slow.

Existing treatment of CML has increased the survival time from an average of three to four years, to five to eight years, but even so, 10 per cent of all patients diagnosed die within two years.

Initially CML is without obvious symptoms and is diagnosed after a blood test, usually done after a patient's vague complaints of tiredness, loss of weight, poor appetite, night sweats and abdominal discomfort, or later, if they have enlarged lymphatic glands.

04 Dec 00 - Medicine - Technique eases pain of cancer treatment

By David Charter, Health Correspondent

Times ... Monday 4 December 2000

The use of a pioneering method of targeting tumours could mean an end to the hair loss and sickness caused by cancer treatments such as chemotherapy, doctors at London's Royal Free Hospital believe.

Research into the new technique for tackling neuroendocrine tumours, the so-called "quiet cancer", has shown some early success with patients who would otherwise have died. Three out of 11 patients who volunteered for the treatment had their tumours reduced. The progress of the cancer appears to have been halted in a further four.

Doctors believe that if they can refine the method of carrying drugs directly to the neuroendocrine tumour, the practice could be extended to brain, breast and lung cancer. Readers of The Times are being asked to support the work at the Royal Free in a Christmas Appeal by contributing towards the £50,000 needed for a research fellowship.

John Buscombe, consultant in nuclear medicine at the hospital, said: "Donations from readers of The Times will go towards ensuring that there's a better understanding of the biology so we know how to treat these tumours better. It is what we call a model - we work with one particular tumour and if we can prove the concept works then it should draw investment to look at different tumour groups.

"We are treating some brain tumour patients as well and the next things to look at would be small-cell lung cancer and breast cancer."

The compound used, octreotide, behaves like a hormone, homing in on the tumour. This provides a method of early detection and can also be used to attack symptoms.

It could bring several benefits which are lacking with chemotherapy. First, if the chemical marker attaches to the tumour, it shows that the patient is likely to respond to drugs delivered in the same way. The treatment is therefore only used on those most likely to benefit. Second, the drugs are carried directly to the tumour, saving the pounding which the whole body takes in chemotherapy. Third, the drugs can be made comparatively cheaply.

Dr Buscombe said: "We are trying to turn away from saying, 'Let's treat 100 people the same and hope that 20 get better', to 'Let's find out if it is likely to work and treat those who will benefit'. Toxicity is low because the drugs only go to the tumour and attack the tumour cells, not the body. Your hair doesn't fall out, you don't feel sick and we may be able to treat people on an out-patient basis. It's a win-win situation but the only thing we need are the resources and the Times appeal will help with that."

Readers are also asked to contribute to the £35,000 cost of a cancer nurse for the country's foremost cancer advice service. The CancerBACUP free phoneline - 0808-800 1234 - helps 50,000 a year.

British researchers believe that they have made an important breakthrough in the search for a vaccine against the crippling digestive illness Crohn's disease .

As many as 80,000 people in Britain are stricken by the condition, which leads to a chronic inflammation of the intestine, wrecking patients' lives. It is becoming increasingly common with 4,000 to 8,000 new cases a year.

John Hermon-Taylor, professor of surgery at St George's Hospital in south London, links the illness with a TB-like bacterium called MAP (mycobacterium avian subspecies paratuberculosus) which causes a similar illness in cattle, sheep, pigs and primates.

Professor Hermon-Taylor believes that MAP is contaminating the human food chain. While it may be tolerated by most people, the consequences for a minority who are susceptible can be disastrous. A study by the Food Standards Agency this year established that the bacterium can survive pasteurisation and found it in more than two per cent of both pasteurised and unpasteurised milk samples.

Now Professor Hermon-Taylor is developing a therapeutic vaccine to treat patients. Professor Hermon-Taylor says that the bacterium is resistant to standard anti-TB drugs and has learned to "hide" from the body's immune defences by invading white blood cells. Its hidden presence unbalances the delicate physiology of the gut, making it leaky to other bacteria and food molecules, triggering inflammation.

Researchers at St George's have identified five key molecules on its surface and the gene for each, and used this DNA to make a vaccine that appears to help the immune system attack MAP. Experiments in mice have shown that, when combined with a common harmless virus, the DNA for these molecules can induce an immune response involving white blood cells, the appropriate weapon against TB-like infection.

With the help of a £160,000 grant from the charity Action Research, further studies are now planned to see if the vaccine can protect against MAP infection. Human trials could start in three to five years. Three quarters of Crohn's disease sufferers need major surgery. A careful diet and anti-inflammatory drugs can help but there is no cure.

The Government's Advisory Committee on the Microbiological Safety of Food has said that transmission to humans of MAP from milk is not proven. However, the FSA wants it kept out of food for human consumption.

If Professor Hermon-Taylor's vaccine works it will prove his belief that MAP is responsible for most cases of Crohn's disease, an illness that has baffled doctors. Professor Hermon-Taylor said: "I am absolutely certain that this bug can cause Crohn's disease. I don't know whether it causes 60 per cent of cases or 90 per cent but it is a cause."

Professor Hermon-Taylor said: "We are extremely confident that the vaccine will work but we now have to test it thoroughly before we can start human trials." In studies a majority of people with Crohn's disease have tested positive for MAP, and antibiotics that knock out the bacterium improve the health of about two thirds of sufferers.

The professor says that MAP is highly resilient, and, milk apart, has also got into the water supply by being washed off fields where cattle graze. Professor Hermon-Taylor's research has been supported by Scottish government scientists, who found that MAP was spread to some cattle by the soiling of pasture by infected rabbits.

Milk companies are heating milk for longer to try to kill the bug but there are worries that the bug might also be entering the food chain via the consumption of meat from infected animals. Because the organism has a long incubation period - at least 15 months - farmers seldom detect signs of it in their herds.

The professor said: "We ought to be eliminating it from the food chain but it is not being identified at the slaughtering stage and must get through the system." Action Research suggested that people with Crohn's or relatives with the disease might be wise to use UHT milk, which is heated to a higher temperature.

Ann Luther, the director general of Action Research, said: "We are glad to be able to build on Professor Hermon-Taylor's earlier findings with the clear objective of protecting people from the devastating effects of Crohn's disease."

03 Dec 00 - Medicine - Sex changes on NHS to triple

Nicholas Rufford

Sunday Times ... Sunday 3 December 2000

The number of sex-change operations carried out on the National Health Service is set to triple in a move that will provoke a bitter row over the allocation of scarce resources.

Charing Cross hospital in central London, which performs most of the sex-change operations financed by taxpayers, is to increase the number of operations it carries out from one a week to three a week at an extra cost of about £1m a year.

A consultant surgeon specialising in "gender reassignment" will be appointed in the next few days on a £60,000 salary to lead a team of clinicians carrying out the extra work. Administrators say they are reacting to a huge increase in demand from health authorities.

Other leading surgeons reacted angrily to the news, saying the money could be better spent cutting waiting lists for essential treatment, particularly hip and prostate operations for the elderly. Alan Milburn, the health secretary, is already under fire over the government's announcement last week that it will issue new rules for fertility treatment. Experts say it will cost the NHS millions of pounds.

Liam Fox, the shadow health secretary and a former hospital doctor, accused Labour of pandering to lobby groups at the expense of the elderly. "It is completely unacceptable that patients with life-threatening conditions are denied treatment while an ever increasing amount of money is spent on sex-change operations," he said. "It shows how far out of touch with public opinion Labour's health policies are."

The £10,000 sex-change operations at Charing Cross consist of the removal of male genitalia and the creation of a replica vagina. The operation involves a lead surgeon, usually a plastic surgeon or urologist, an anaesthetist and other staff. It takes about three hours and the patient is hospitalised for a week. With the same resources, at least two patients needing prostate surgery could be treated.

Follow-up surgery is often required for sex-change patients. Many have breast enhancement and surgery on the larynx to alter the voice, also available on the NHS. Scores of applicants are awaiting operations.

Grant Williams, a urologist who resigned from Charing Cross when it carried out early sex changes more than a decade ago, said the operations should be at the foot of the list of priorities. "It is sad when a patient who can't pass urine is sent home with a catheter because there are not enough beds, while other beds are allocated for transsexual surgery," he said.

Patients needing prostate operations - for non-cancerous conditions - wait at least three months and often as long as six months for surgery at Charing Cross.

Professor Simon Carter, head of urology at Charing Cross, who manages the sex-change unit, said there had been a huge increase in patients wanting the operation. "The demand has gone beyond what we set the level of service at. We live in a more tolerant society so people are less shy about coming forward for the operation."

The government is drawing up plans for performance-related pay for doctors as part of its plan to reform NHS contracts and prevent newly qualified consultants from doing private work. It will scrap the existing merit award system for consultants, which allows doctors to award bonuses of up to £60,000 to colleagues.

03 Dec 00 - Medicine - Mothers to be sent home six hours after giving birth

Sue Leonard, Scottish Health Correspondent

Sunday Times ... Sunday 3 December 2000

New mothers will be expected to go home just six hours after giving birth at one of Scotland's largest maternity units. A senior hospital director is believed to have resigned in protest, The Sunday Times has learnt.

Midwives and patient groups say health officials are looking to significantly reduce the stay in hospital when maternity services move to the new Edinburgh Royal Infirmary site in February 2002, to cut costs and free more beds. They are worried that the move could lead to a fall in breast-feeding and an increase in post-natal depression.

The resignation of Margaret Stewart, head of midwifery services at Lothian University Hospitals Trust, is believed to be linked to the cost-cutting move.

Women currently stay in hospital for an average of two and a half days, although some hospitals in Scotland are known to be moving towards 24 and even 12-hour discharges.

Midwives have told The Sunday Times that the majority of women having uncomplicated births at the new maternity unit at Little France will be encouraged to go home six hours after giving birth, including first-time mothers.

About 70% of women giving birth in Lothian have normal deliveries.

A radical overhaul will lead to a return to community-based services not seen since the 1940s, in which most of the ante-natal and postnatal care will take place outside hospital.

One midwife, who did not wish to be named, said that "domino" deliveries - based on a model of care in which women are taken into hospital by their own midwives, who deliver the babies and then transfer them home soon after birth - would be significantly increased.

The National Childbirth Trust (NCT) and the patient watchdog Lothian Health Council said that they were aware of the plans but stressed that women should be able to choose when to go home.

Maternity beds in Edinburgh have declined from 156 in 1995 to 101 in 1999. After the closure of the maternity unit at the Eastern General in 1998, the Simpson Memorial Maternity Pavilion at the ERI is the only maternity unit in the city, and deals with about 7,000 deliveries a year. There will be 97 beds in the new hospital at Little France.

A number of midwives who spoke to The Sunday Times said they were worried that women would feel pressurised into going home before they were ready to cope with the demands of motherhood.

"There is a concern that people will be rushed in and out," said one. "You do not know if there is going to be a problem until you have been there for 24 hours.

"A lot of babies are very sleepy after birth and do not want to feed. Inexperienced mums may run into difficulties, especially with breast-feeding."

Kathy McGlew, of the NCT, said the situation at the Simpson was already dire. "There is no time for anything," she said. "People are waiting for beds in labour wards."

Deborah Purdue, an independent midwife, said: "My concern is that the hospital management will put pressue on the midwives to achieve this when the midwives feel it is not appropriate."

Sarah Macdonald, chairman of the Lothian maternity liaison group, said the philosophy behind an enhanced community midwife service was to give women better continuity of care and more choice.

She said plans were still being developed but denied that a six-hour discharge policy was to be implemented.

An anti-cancer pill that offers new hope to thousands of leukaemia victims is to be launched next year after tests showed that it saved the lives of up to 40% of patients suffering from one form of the disease.

Until now toxic chemotherapy drugs or a bone marrow transplant have been the only hope for sufferers of chronic myeloid leukaemia (CML).

It affects 4,000 people a year in Britain, killing most within five years. The new drug, Glivec, prevents the fatal multiplication of white blood cells which occurs in leukaemia.

The results from an international study carried out on 1,000 CML sufferers treated with the drug in capsule form will be announced at a haematology conference being held in San Francisco tomorrow.

The tests were conducted on groups of patients suffering at different stages of the disease. Among those who were at the second stage, which is usually the hardest to treat, 20% were completely or almost cleared of the disease, and a further 60% showed improvement after just four weeks of treatment.

Among the group of patients with the disease in its first stage, nearly 40% were completely or almost cleared, while doctors found that just less than 60% showed some improvement after between three and six months of treatment.

Glivec, which was codenamed STI571, was developed by Nick Lydon, a British scientist working for the Swiss pharmaceutical company Novartis, and Brian Druker, professor of haematology and oncology at Oregon Health Sciences University.

Druker discovered that STI571 was particularly effective in fighting CML, which is a comparatively rare form of leukaemia.

The drug is already being used in trials to treat lung and bowel tumours, and doctors have been encouraged by the early results.

Last week, Daniel Vasella, the chairman of Novartis, was presented with an award for the drug at a New York ball attended by President Bill Clinton.

Glivec has provided one of the first successful ways to target key proteins that fuel the growth of cancer. The standard approach of chemotherapy is to use highly toxic drugs to destroy entire populations of cells, with the aim of killing the cancerous ones. However, the side effects of this method can often be fatal.

Scientists believe the new generation of "smart" drugs such as Glivec will lead the way in developing treatments for other forms of cancer.

In Britain at least 10,000 people a year contract leukaemia or related cancers, and it is hoped that they could also eventually benefit.

Stephen O'Brien, who has been leading the Glivec trials at the Royal Victoria Infirmary in Newcastle upon Tyne, said: "We believe this is a major breakthrough, which paves the way for development of new types of anti-cancer drugs that might improve survival with minimal side effects and good quality of life."

One participant in the tests was Sandy Craine, 50, an artist from London, who was diagnosed with the disease in December 1998.

She temporarily moved to America to be guaranteed a supply of Glivec. She began taking it in August last year and has undergone a rapid improvement.

"They did not give me much chance of getting through a transplant but this drug is wonderful. It has given me hope and a future," she said.

Doctors have been given the right to hand out fruit and vegetables to patients on the National Health. And in some areas, the overweight, stressed-out and smokers can even be given a session at the local gym by their GP.

The free prescriptions for anything from a couple of kiwi fruit to a pound of carrots are part of a scheme being tested in Wallasey, in the Wirral, Cheshire, and shortly to be extended throughout the borough.

It is among several NHS-backed initiatives to make the nation fitter and more health-conscious which will be outlined at a conference in London on Tuesday.

Sue Drew, a sports scientist and health promotion manager of Wirral and West Cheshire Health Trust, said: "What the doctor, or health visitor will prescribe is actually a weight management programme and if as a part of this programme the patient needs to increase his or her consumption of fruit and vegetables they will get a voucher for free supplies from their local store.

"Anyone over 16 is eligible but obviously we want to target those more disadvantaged people who are less likely to be eating enough fruit and vegetables.''

Andy Worthington, director of leisure for Wirral Metropolitan Borough Council, said anyone could walk into one of the 80 GP practices in the area and get exercise on prescription. "Instead of drugs, sedatives or other medication, the doctor can prescribe a course at a local leisure centre, or other activity area such as community centres or libraries where the patient is monitored and given an exercise programme,'' he said.

A similar scheme operates in the London boroughs of Camden and Islington.

''Originally we set up an activity programme using sport and exercise to reduce the risk of falls among the elderly,'' said Sam Anderson, the physical activities officer. "This has now been extended to cardiac rehabilitation. Falls among the elderly cost the NHS around £940m and if we can prevent someone from fracturing their hip it represents a saving of around £20,000.''

Among the positive links between sport, exercise and health, designed to ease the strain on the NHS, to be outlined at Tuesday's "Fitness for Life'' conference organised by Sport England in conjunction with the Health Development Agency, are tai-chi for older people in Camden, dance classes for teenagers in Bradford and PE lessons for pupils with physical disabilities in Birmingham.

The need to promote exercise, games and diet as a means of reducing the strain on the NHS will be emphasised by Chris Smith, Secretary of State for Culture, Media and Sport, and the health minister Yvette Cooper.

Breast cancer could soon be predicted at birth among most women , researchers suggested yesterday.

The largest study of the link between genes and the disease found that a much higher proportion of breast cancer cases, and perhaps the majority, were among women who were genetically susceptible.

Prof Julian Peto, lead author of the study published in Nature Genetics by scientists at the Institute of Cancer Research, Surrey, suggested that such susceptibility may be caused by an "unlucky combination of normal genes". Women thus affected were at a higher risk of cancer being triggered by environmental factors.

Prof Peto said: "We now believe that breast cancer susceptibility may be largely decided at birth. The risk can be increased or reduced by dietary and reproductive factors, but a minority of women begin life with much higher susceptibility to such factors. This signals a major shift in direction in research into the disease."

Efforts are already under way to find the constellations of genes that place women at high risk so that, within a few years, it will be possible to screen susceptible women more often and target them with drugs and advice.

The discovery radically changes scientists' perceptions of the way genes and environmental factors may contribute to development of the disease. To date, two major cancer genes have been found; BRCA1 and 2. However, they account for only two per cent of cases and scientists had estimated that one in 10, or less, of cases were caused by genetic factors.

Prof Peto and Dr Thomas Mack, of the University of Southern California, studied almost 15,000 relatives of breast cancer patients, including 1,340 identical twins, 970 non-identical twins and 12,428 mothers and sisters.

A striking pattern emerged when comparing families struck by the disease - the risk did not vary between families, only the age at which the high risk appeared; from 30 to over 50. Prof Peto said: "If you get cancer at 30, then from the age of 30 onwards your mother and sisters and daughters, your other breast and your identical twin, if you have one, have a high constant rate of incidence of the disease."

Earlier studies of the risk of women with breast cancer in one breast later developing it in the other found that their relatives displayed a constant annual risk of developing the disease - a similar pattern to the risk among the patients of developing cancer in their second breast.

The identical twins of breast cancer patients also followed this pattern. The difference in risk between identical and non-identical twins suggested that inherited factors were largely responsible. About 35,000 women in Britain develop breast cancer every year and 13,000 die.

02 Dec 00 - Medicine - Model in NHS smoking advert has emphysema

Christy Turlington's lungs will never recover from the damage caused by a decade of smoking, doctors said yesterday. The supermodel, who is fronting an NHS anti-smoking campaign, found she was suffering from early-stage emphysema when she volunteered for a lung scan in the United States. She is 31 and gave up smoking five years ago.

As the face of Calvin Klein, Turlington is a fashion icon. She said she was shocked by the discovery but hoped it would help to deter young people from taking up the habit.

She said: "Generally they don't discover emphysema until you are much older. The really frightening thing is there was enough of an effect that it caused permanent damage."

Studies show that young girls are influenced by female role models, and many smoke to keep their weight down. Smoking among teenage girls is higher than among boys and lung cancer rates among women are rising.

Turlington started smoking at 13, stealing her father's cigarettes, and was up to a packet a day at 16. She tried to give up at 19 but was smoking again at 21. She finally shook the habit at the age of 26. She became an ardent anti-smoking campaigner after her father died of lung cancer in 1997.

Emphysema is caused by an imbalance in the enzymes in the lung, caused by smoking, leading to the breakdown of lung tissue. The tissue develops holes, reducing the surface area and leading to breathlessness. The bronchial tubes lose their elasticity, making it harder to get air in and out. Genes play a part, and some susceptible individuals are seriously affected in their teens.

Dr John Moore-Gillon, a consultant at St Bartholomew's in London and a spokesman for the British Lung Foundation, said: "Christy Turlington did exactly the right thing by giving up smoking and her outlook is good. But her lungs won't recover. However... so long as she does not want to be a marathon runner she should be all right."

The arguments over affordable life-saving medicines for the developing world intensified yesterday when it was revealed that the multinational pharmaceutical company Glaxo-Wellcome has blocked imports of cheap copies of one of its Aids drugs into Ghana.

The revelation came as South Africa announced it had done a deal with a second company, Pfizer, over supplies of the drug Fluconazole to treat infections such as meningitis that often kill people whose immune systems are wrecked by the Aids virus HIV.

Under pressure from campaigners, who began bringing a cheaper version of the patent-protected branded drug into South Africa which massively undercut the usual Pfizer price, the company has agreed to supply Fluconazole free.

But although aid organisations such as the charity Médecins Sans Frontières (MSF) hailed the deal as an example of what can be achieved if countries show a willingness to turn their back on the pharmaceutical giants and buy copies, Britain made it clear yesterday that it was not in favour of such tactics.

Trade minister Richard Caborn told activists from the London-based organisation Action for Southern Africa (Actsa) that such measures "are not the answer here".

Campaigners insist that developing countries must use every possible means to get hold of affordable drugs that can stop people dying. But western governments say the companies have a right to protection for the drugs they sell at high prices in order, the companies argue, to recoup research and development costs.

The west says the right approach is for countries to negotiate discounts with the companies. But African nations say they cannot afford the drugs even at the discount prices offered in May this year by five multinationals. Only Senegal has so far taken up the invitation to negotiate a deal.

The giants take very seriously the threat of competition. Glaxo-Wellcome has blocked the import into Ghana of a version of its Aids therapy Combivir made in India by Cipla.

It is argued by campaigners that impoverished countries faced with a health emergency have a right under international trade legislation to buy generic drugs. The African Regional Industrial Property Organisation was quoted yesterday as saying that if Glaxo went to court, it believed it would lose. But poor countries fear confrontation will upset relations with the west.

Glaxo's spokesman said the company had offered Ghana its own drugs under its "preferential pricing" scheme.

The price for the generic version of Combivir has not been revealed, but generics sell for a fraction of the branded price. MSF has gathered data showing that Cipla sells Fluconazole for $0.64 (45p) in India, compared with Pfizer's price in South Africa of $8.25 and in Kenya of $10.56.

MSF pointed out yesterday that AZT and 3TC, the two drugs in Combivir, are both old and that they were developed with the help of public funds in the United States. GlaxoWellcome has already made many millions out of them. "It cannot argue it needs to recoup its investment," said a spokesman.

Actsa says that the threat of generic competition made Pfizer lift restrictions it wanted to impose on the Fluconazole it is donating to South Africa. "At first it was going to be only for meningitis and not for thrush, which affects more people. The company was dictating how the drug was to be used," said a spokesman.

The Pfizer deal was announced the day after South Africa's medicines control council said it would allow generic Fluconazole to be used in the country.